Novel Device for Reducing Catheter-Related Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878683
Recruitment Status : Withdrawn (Never received IRB approval; Withdrawn before enrollment ever started)
First Posted : April 9, 2009
Last Update Posted : May 5, 2015
University of Missouri-Columbia
Information provided by:
University of Kansas Medical Center

Brief Summary:
This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.

Condition or disease Intervention/treatment Phase
Intensive Care Device: silicone catheter boot Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections
Study Start Date : July 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: 1
Device and standard catheter
Device: silicone catheter boot
silicone device using Dermabond

No Intervention: 2
Standard catheter

Primary Outcome Measures :
  1. Catheter site inspection [ Time Frame: Baseline, Daily ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admission in the ICU at time of catheter insertion
  • Indication for central venous catheter placement
  • De novo catheter insertion in the subclavian or internal jugular veins

Exclusion Criteria:

  • Anticipated catheter duration < 72 hours
  • Planned guidewire exchange
  • Documented bacteremia within 48 hours prior to catheter placement
  • Extensive skin breakdown near the site of potential catheter placement
  • Emergent line placement
  • Screening labs with ANC < 500 or platelets < 50K
  • Hypersensitivity to cyanoacrylates or formaldehyde
  • Prior enrollment in study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878683

Sponsors and Collaborators
University of Kansas
University of Missouri-Columbia
Principal Investigator: Stephen Waller, MD University of Kansas Medical Center

Responsible Party: Stephen Waller MD, University of Kansas Medical Center Identifier: NCT00878683     History of Changes
Other Study ID Numbers: 11525
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Catheter-Related Infections